(266 days)
Not Found
No
The summary describes a mechanical catheter for contrast delivery and pressure measurement. There is no mention of AI/ML in the device description, intended use, or performance studies.
No.
The device is used for diagnostic purposes (delivery of contrast medium and pressure measurement) and not for treating or preventing a disease or condition.
Yes
The device is used for simultaneous pressure measurement from two sites to determine transvalvular, intravascular, and intraventricular pressure gradients, which is a diagnostic function.
No
The device description clearly details physical components like a coaxial tube, braided catheter shaft, extension line, stopcock, and manifold, indicating it is a hardware device.
Based on the provided information, the Langston dual lumen catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of contrast medium in angiographic studies and for simultaneous pressure measurement. This is a direct medical intervention performed in vivo (within the body) for diagnostic imaging and physiological measurement.
- Device Description: The description details a catheter designed to be inserted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the body. The Langston dual lumen catheter is a medical device used within the body for imaging and pressure measurement.
N/A
Intended Use / Indications for Use
The Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressurement is useful in determining transvalvular, intravascular, and intraventricular pressure gradients.
Product codes
DQO
Device Description
The Langston dual lumen catheter consists of a coaxial tube (outer lumen) mounted over a braided catheter shaft (inner lumen) and an extension line with a 3-way stopcock. The extension line with stopcock connects to the outer lumen. The outer lumen, and extension line are joined by an over molded manifold. The manifold also includes a luer that connects to the inner lumen. The manifold is printed with the Langston catheter length, French size, maximum guidewire diameter, and product logo ("Langston"). The Langston dual lumen catheter tip terminates in either a pigtail or multipurpose tip configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The technological differences between the subject and predicate devices have been evaluated through biocompatibility and bench tests to provide evidence of Langston dual lumen catheter substantial equivalence. Clinical testing was not performed to validate the performance of the subject device. The Langston dual lumen catheter is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:
- . Package Integrity
- . Tortuosity in Simulated Anatomy
- Pressure Monitoring
- Flow Rate vs. Injection Pressure
- . Tensile Force
- Torque to Failure
- Air Leakage During Aspiration
- . Liquid Leakage Under Pressure
- . Torque Strength
- Dimensional Analysis
- . Hub Luer Taper
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- . Cytotoxicity
- Sensitization .
- Irritation
- Acute Systemic Toxicity
- . Pyrogenicity
- Hemocompatibility
The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 17, 2017
Vascular Solutions, Inc. Jake Schultz Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369
Re: K170544
Trade/Device Name: Langston Dual Lumen Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: October 10, 2017 Received: October 11, 2017
Dear Jake Schultz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170544
Device Name Langston Dual Lumen Catheter
Indications for Use (Describe)
The Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressurement is useful in determining transvalvular, intravascular, and intraventricular pressure gradients.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared: 11/15/2017
510(k) Number: K170544
Submitter's Name / Contact Person
| Manufacturer | Contact |
|---|---|
| Vascular Solutions, Inc. | Jake Sch |
| 6464 Sycamore Court North | Regulatory |
| Minneapolis, MN 55369 USA | Tel: 763 |
| Establishment Registration # 2134812 | Fax: 763 |
Person ultz ory Product Specialist -656-4300 3-656-4253
General Information
| Trade Name | Langston dual lumen catheter |
|---|---|
| Common / Usual Name | Diagnostic intravascular catheter |
| Classification Product Code | DQO |
| Classification Name | 21 CFR 870.1200 Diagnostic intravascular catheter |
| Predicate Devices | K061565, Langston dual lumen catheter, Vascular Solutions, Inc |
| K051395, Langston dual lumen catheter, Vascular Solutions, Inc |
| K170544 Device Models | |||||
|---|---|---|---|---|---|
| Model | Description | Length | Outer | ||
| Lumen | |||||
| Diameter | Inner Lumen | ||||
| Diameter | Max Pressure | ||||
| Rating | |||||
| 5515 | 145° Pigtail | 125 cm | 7 F | 5 F | 1200 psi |
| 5540 | 145° Pigtail | 110 cm | 6 F | 5 F | 1000 psi |
| 5550 | Multipurpose A2 | 100 cm | 6 F | 4 F | 1000 psi |
Device Description
The Langston dual lumen catheter consists of a coaxial tube (outer lumen) mounted over a braided catheter shaft (inner lumen) and an extension line with a 3-way stopcock. The extension line with stopcock connects to the outer lumen. The outer lumen, and extension line are joined by an over molded manifold. The manifold also includes a luer that connects to the inner lumen. The manifold is printed with the Langston catheter length, French size, maximum guidewire diameter, and product logo ("Langston"). The Langston dual lumen catheter tip terminates in either a pigtail or multipurpose tip configuration.
4
Intended Use
The Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular, and intraventricular pressure gradients.
Technological Characteristics Comparison
The Langston dual lumen catheter has identical indications for use and principle of operation as the predicate devices and they are all diagnostic intravascular catheters. The subject and predicate devices are intended for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. The Langston dual lumen catheter is equivalent in design and technological characteristics to the predicate devices. The subject and predicate devices are dual lumen catheters sterilized via ethylene oxide and intended for single use. The proximal manifold of the Langston dual lumen catheter will be modified to remove the adhesive bonds and replace it with an over molded proximal manifold component. The manifold component introduces Nylon 12 Grilamid as a new material to the Langston dual lumen catheter. The extension line tubing material of the Langston dual lumen catheter will also be modified to increase stiffness and to remove the adhesive bond by including an additional strain relief.
Substantial Equivalence and Summary of Studies
The technological differences between the subject and predicate devices have been evaluated through biocompatibility and bench tests to provide evidence of Langston dual lumen catheter substantial equivalence. Clinical testing was not performed to validate the performance of the subject device. The Langston dual lumen catheter is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and indications for use. The device design has been verified through the following tests:
- . Package Integrity
- . Tortuosity in Simulated Anatomy
- Pressure Monitoring
- Flow Rate vs. Injection Pressure ●
- . Tensile Force
- Torque to Failure
- Air Leakage During Aspiration ●
- . Liquid Leakage Under Pressure
- . Torque Strength
- Dimensional Analysis ●
- . Hub Luer Taper
5
Device samples passed the following biocompatibility tests performed in accordance with ISO 10993-1:
- . Cytotoxicity
- Sensitization .
- Irritation ●
- Acute Systemic Toxicity ●
- . Pyrogenicity
- Hemocompatibility
The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Langston dual lumen catheter is substantially equivalent to the predicate devices.